The following data is part of a premarket notification filed by Cardiocom Llc with the FDA for Commander Iii Non-invasive Blood Pressure System.
| Device ID | K053304 |
| 510k Number | K053304 |
| Device Name: | COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CARDIOCOM LLC PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-28 |
| Decision Date | 2005-12-30 |
| Summary: | summary |